The domestic substitution of medical-grade fluorosilicone rubber is accelerating, and breakthroughs have been made in the application of precision medicine
With the continuous breakthroughs in biocompatibility technology, domestic medical-grade fluorosilicone rubber has achieved rapid development in recent years. Not only has the number of products certified by international authoritative authorities increased significantly, but it has also made application breakthroughs in precision medicine fields such as minimally invasive surgical instruments and interventional catheters, breaking the long-term pattern of import dependence and providing core material support for the upgrading of domestic medical equipment industry.


1. Technological breakthrough: The core indicators of biocompatibility compliance are on par with international standards
The core technical difficulty of medical-grade fluorosilicone rubber lies in its biocompatibility and stability against the human environment. Domestic enterprises have achieved breakthroughs in key indicators through molecular structure modification and purification process optimization. Test data shows that the cytotoxicity of domestic medical-grade fluorosilicone rubber reaches the ISO 10993-5 standard Class VI level. After being immersed in a simulated human body environment for 1000 hours, the performance degradation rate is less than 8%, fully meeting the requirements of implantable medical devices. At present, five domestic enterprises have obtained the EU CE certification for their products, and some of their products have passed the US FDA 510(k) certification. Their core performance indicators are on par with international brands, while their prices are 12% to 15% lower than those of imported products, demonstrating significant market competitiveness.

2. Application Expansion: Multiple breakthroughs from conventional medical devices to precision medicine
The application scenarios of domestic medical-grade fluorosilicone rubber are extending from traditional medical devices to the field of precision medicine. In the field of minimally invasive surgery, instrument seals made of domestic fluorosilicone rubber have been widely used in laparoscopes, arthroscopes and other equipment due to their excellent sterilization resistance and flexibility. Their service life is more than three times longer than that of traditional materials. In the field of interventional therapy, customized fluorosilicone rubber catheters have been successfully applied in cardiovascular interventional surgeries due to their excellent biocompatibility and molding accuracy, contributing to the improvement of surgical precision. Data shows that in the first half of 2024, domestic medical-grade fluorosilicone rubber achieved its first net export in a single month, marking that domestic products have gained recognition in the international market.

3. The dual drive of policies and capital accelerates the large-scale development of industries
Policy support and capital investment have injected strong impetus into the development of medical-grade fluorosilicone rubber industry. The National Key Special Project for New Materials has continuously initiated related research projects for three years, with a total investment of over 500 million yuan in research and development funds. Local governments have simultaneously introduced supporting policies to provide special subsidies for products that have passed international medical certifications. The heat of the capital market continues to rise. In 2023, the number of industry-related merger and acquisition cases increased by 40% year-on-year. Vertical integration of raw material supply and horizontal expansion of application scenarios have become the main investment logics. At present, two major medical-grade fluorosilicone rubber industrial clusters have been formed in China, namely the Yangtze River Delta and the Pearl River Delta. The concentration of production capacity has been continuously increasing, and the capacity utilization rate of leading enterprises has remained above 92% for three consecutive years.

4. Future Outlook: 3D printing combined with intelligent response opens up a blue ocean market worth hundreds of billions
Looking to the future, medical-grade fluorosilicone rubber is developing towards functionalization and customization. Progress has been made in the research and development of 3D printing photocurable fluorosilicone materials, enabling the personalization of complex-structured medical components